| CTRI Number |
CTRI/2024/10/075326 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two doses of Dexamethasone to prevent low blood pressure after Spinal Anaesthesia: A Clinical Study |
|
Scientific Title of Study
|
Comparison of Two Different Doses of Dexamethasone for Attenuation of Post Spinal Anaesthesia Hypotension: A Prospective, Randomized, Double-blind, Clinical Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anita Saran |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Department of Anaesthesiology
AIIMS Rajkot
Rajkot, Gujarat
Rajkot
GUJARAT
360110
India |
| Phone |
8422000468 |
| Fax |
|
| Email |
dranitasaran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Khushboo Pandey |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Department of Anaesthesiology
AIIMS Rajkot
Rajkot, Gujarat
Rajkot
GUJARAT
360110
India |
| Phone |
9888530182 |
| Fax |
|
| Email |
khushboo0411@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Khushboo Pandey |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Department of Anaesthesiology
AIIMS Rajkot
Rajkot, Gujarat
Rajkot
GUJARAT
360110
India |
| Phone |
9888530182 |
| Fax |
|
| Email |
khushboo0411@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Rajkot,
Rajkot, Gujarat,
India-360110 |
|
|
Primary Sponsor
|
| Name |
AIIMS Rajkot |
| Address |
AIIMS Rajkot,
Rajkot, Gujarat,
India- 360110 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anita Saran |
Aiims Rajkot |
Operation Theatre Complex,
Department of Anaesthesia, Ground floor,
IPD Building
Rajkot
GUJARAT |
8422000468
dranitasaran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group D4 |
Patients will receive Dexamethasone 4 mg diluted in 100 ml 0.9% normal saline (NS) IV infusion over 15 min 2 hours preoperatively |
| Comparator Agent |
Group D8 |
Patients will receive Dexamethasone 8 mg diluted in 100 ml 0.9% normal saline (NS) IV infusion over 15 min 2 hours preoperatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grdae I, II & III patients posted for elective lower abdominal and lower limb surgeries under spinal anesthesia.
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Emergency surgery
Pregnant patients
Any contraindications to spinal anaesthesia
Patients on steroids |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients who developed Post Spinal hypotension (PSH) within 20 minutes of spinal anaesthesia. |
Mean blood pressure (MBP) will be recorded before giving the study medication (base line) and then after Spinal Anaesthesia every 5 min for 20 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Severity of Post Spinal hypotension (PSH). |
After spinal anaesthesia till 6 hours post operative period. |
| Number of patients requiring ephedrine/atropine. |
After spinal anaesthesia till 6 hours post operative period. |
| Total dose of ephedrine required. |
After Spinal anaesthesia till 6 hours post operative period |
Effect on perioperative blood glucose levels.
|
Before giving test drug, then at the interval of 2 hours, 4 hours and 6 hours. |
| Occurrence of other side effects (nausea/vomiting/shivering). |
After spinal anaesthesia till 6 hours of post opertive period. |
|
|
Target Sample Size
|
Total Sample Size="184"
Sample Size from India="184"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Spinal anaesthesia is the preferred mode of anaesthesia for infra-umbilical surgeries owing to its simplicity, ease, better post-operative analgesia and lesser side effects like nausea and vomiting. However, hypotension is a common complication after SA with a reported occurrence in 16–33% of cases which limits its use in some patients. Various methods like volume loading and vasopressor injection have been utilized to attenuate post-spinal hypotension (PSH) with varied success. Limited research is available comparing the efficacy of dexamethasone to attenuate PSH. Hence, this study aims to compare the effect of 4 and 8 mg of IV dexamethasone in prevention of PSH. After taking the informed consent, patients will be randomly assigned to one of either group- Group D4 (Dexamethasone 4mg) or Group D8 (Dexamethasone 8mg). Two hours prior to Spinal Anaesthesia patient will receive IV 100ml of 0.9% Normal Saline in which the study drug will be dissolved as per the group allocation (Dexamethasone 4mg/ 8mg). The rest of the procedure will be as per standard care of the operation. During perioperative period, patient will be evaluated for hypotension, bradycardia, blood glucose levels, requirement of vasopressors and occurrence of other side effects like nausea, vomiting and shivering. |